Lymphatic Function in Patients With a Fontan-Kreutzer Circulation

December 19, 2017 updated by: University of Aarhus

The Lymphatic Morphology and Function of Fontan-Kreutzer Operated Patients

The lymphatics regulate the interstitial fluid by removing excessive fluid. It represents an extremely important step in the prevention of edema. The Fontan-Kreutzer procedure has revolutionized the treatment of univentricular hearts. However, it is associated with severe complications such as protein-losing enteropathy (PLE) and peripheral edema that may involve the lymphatic circulation.

Our hypothesis is that patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature, which predisposes them to developing complications such as edema and PLE.

The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF. The anatomy is described using non-contrast MRI and the capillary filtration rate is measured using plethysmography.

Study Overview

Detailed Description

Background:

The lymphatics regulate the interstitial fluid by removing excessive fluid. It represents an extremely important step in the prevention of edema. The Fontan-Kreutzer procedure has revolutionized the treatment of univentricular hearts. However, it is associated with severe complications such as protein-losing enteropathy (PLE) and peripheral edema that may involve the lymphatic circulation.

Hypothesis:

Patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature, which predisposes them to developing complications such as edema and PLE.

Material and Methods:

The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF. The anatomy is described using non-contrast MRI and the capillary filtration rate is measured using plethysmography. The study population is patients with Fontan-Kreutzer circulation operated at Aarhus University hospital. Exclusion criteria is BMI>30 and age (years) < 18. The Fontan-Kreutzer group will be compared with an age, gender and weight matched control group of healthy volunteers.

Study Type

Observational

Enrollment (Actual)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients born with an univentricular heart, who surgically is corrected with a Fontan-Kreutzer Circulation

Description

Inclusion Criteria:

  • Fontan-Kreutzer circulation

Exclusion Criteria:

  • BMI>30,
  • Age<18
  • Mental illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fontan-Kreutzer operated patients
Patients with a Fontan-Kreutzer circulation. No interventions are done. (The intervention is the operation done 15-20 years ago)
The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF.
Other Names:
  • Strain-Gauge Plethysmography
The anatomy is described using non-contrast MRI.
The capillary filtration rate is measured using plethysmography
Healthy Control subjects
Age, gender and weight matched control subjects
The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF.
Other Names:
  • Strain-Gauge Plethysmography
The anatomy is described using non-contrast MRI.
The capillary filtration rate is measured using plethysmography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pumping pressure
Time Frame: 1 hour
Occlusion of lymphatic flow by inflating a cuff (Hokanson E20 Rapid cuff inflator, Hokanson AG101 air source) to 70mmHg and then reducing the pressure with 5mmHg each 5th minute. The highest pressure under which the fluorescent dye is able to cross the inflatable cuff is labelled Ppump.
1 hour
Contraction Frequency
Time Frame: 6 min
Contraction frequency in vessels in the main drainage pathway of the legs (ventromedial bundle) as well as vessels draining the area behind the medial malleolus.
6 min
Refill time
Time Frame: 20 min
The time it takes for a 10 cm long vessel to refill after emptying the vessel with massage
20 min
Velocity
Time Frame: 6 min
The velocity measured in cm/s for a packet of lymph moving from one region of interest (ROI) to another through atlas a 5 cm straight vessel
6 min
Capillary Filtration Rate
Time Frame: 25 min
A 5-step 20-min venous congestion protocol will be used to measure capillary filtration. The capillary filtration rate (µl·100 ml-1 ·min-1 ) is measured as the slope of the time-volume change (%) curve at steady state at the end of each pressure phase.
25 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Vibeke E Hjortdal, MD, PhD, Dr.Med, Aarhus University Hospital, Department of Cardiothoracic and Vascular Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2014

Primary Completion (Actual)

June 20, 2017

Study Completion (Anticipated)

August 31, 2018

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 20, 2017

Study Record Updates

Last Update Posted (Actual)

December 20, 2017

Last Update Submitted That Met QC Criteria

December 19, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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